Expandable member systems and methods for drug delivery
Inventors
Stankus, John Joseph • Su, James
Assignees
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Publication Number
US-11672959-B2
Publication Date
2023-06-13
Expiration Date
Abstract
Described here are systems and methods for delivering an active agent to target tissues of the ear, nose, or throat using an expandable member having drug crystals layered thereon, and methods for manufacturing such systems. The expandable member can be delivered to the target tissues in a low-profile configuration and expanded to contact and/or dilate surrounding tissue. Expansion of the expandable member transfers the drug crystals to the target tissues, which then act as an in situ depot that enables maintenance of a therapeutic level of an active agent for a desired time period after removal of the expandable member. Multiple expansions of a single expandable member can be employed during treatment. For example, the systems and methods can be useful when it is desired to treat multiple paranasal sinuses with a single expandable member.
Core Innovation
The invention relates to a system for locally delivering a therapeutically effective amount of an active agent to a surface of a target tissue. The system includes an expandable member sized and shaped for placement in an ear, nose, or throat of a patient, where the expandable member comprises a drug layer at least partially covering an outer surface of the expandable member. The drug layer is designed to contact the target tissue surface after placement.
The drug layer comprises mometasone furoate as drug crystals, with conditions on both the crystal fraction and the average crystal length. One alternative requires at least about 60% of mometasone furoate as drug crystals and an average length greater than about 80 μm to maintain a therapeutically effective amount of at least 0.1 μg/g of mometasone furoate in the target tissue over a treatment period of at least 30 days. A second alternative uses less than about 60% drug crystals with an average length less than about 80 μm to maintain the same therapeutically effective amount over at least 30 days.
Expansion of the expandable member enables transfer of the drug crystals to the tissue to form an in situ depot that maintains therapeutically effective levels after removal, supporting sustained local delivery. The disclosed concept also describes tunable characteristics of the drug layer based on crystalline versus amorphous drug content and the inclusion of excipients, as well as configurations that support partial transfer across single or multiple expansions to deliver to multiple ENT target sites.
Claims Coverage
The independent claim covers a system with three inventive features, directed to local delivery via an expandable member placed in an ear, nose, or throat.
Expandable member for ENT placement with drug layer on outer surface
An expandable member sized and shaped for placement in an ear, nose, or throat of a patient, the expandable member comprising a drug layer at least partially covering an outer surface thereof.
Crystal fraction and average length to maintain 0.1 μg/g for at least 30 days (60%+ crystals, >80 μm)
The drug layer comprises at least about 60% of mometasone furoate as drug crystals and the drug crystals have an average length greater than about 80 μm to maintain a therapeutically effective amount of at least 0.1 μg/g of the mometasone furoate in the target tissue over a treatment period of at least 30 days.
Crystal fraction and average length to maintain 0.1 μg/g for at least 30 days (<60% crystals, <80 μm)
The drug layer comprises less than about 60% of the mometasone furoate as drug crystals and the drug crystals have an average length less than about 80 μm to maintain the therapeutically effective amount of at least 0.1 μg/g of the mometasone furoate in the target tissue over the treatment period of at least 30 days.
Overall, the claim coverage is centered on an expandable ENT-delivery device with a mometasone furoate drug layer whose crystal fraction and average crystal length are set using two alternative conditions to maintain at least 0.1 μg/g mometasone furoate in the target tissue for at least 30 days.
Stated Advantages
Maintains a therapeutically effective amount of at least 0.1 μg/g of mometasone furoate in the target tissue over a treatment period of at least 30 days.
Documented Applications
Locally delivering mometasone furoate to surfaces of target tissue in the ear, nose, or throat of a patient.
Reducing the size of one or more nasal polyps at a target tissue site.
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